NCT02258360

Brief Summary

This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest. The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia Our specific aims are:

  • To investigate the whole blood coagulation using the rotational thromboelastometry.
  • To investigate the function of platelets

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

August 29, 2014

Last Update Submit

March 28, 2016

Conditions

HypothermiaHeart ArrestHemostasisCoagulants

Keywords

ThromboelastometryHaemostasisHypothermiaHeart Arrest

Outcome Measures

Primary Outcomes (2)

  • Clotting time in seconds, EXTEM

    Measured by thomboelastometry on the ROTEM®

    After 46 hours

  • Area under the curve, COL-test

    Platelet function will be measured using Multiplate®

    After 46 hours

Secondary Outcomes (10)

  • Clotting time in seconds, EXTEM

    After 22 hours and 70 hours

  • Clotting time in seconds, -INTEM, FIBTEM and HEPTEM

    After 22 hours, 46 hours and 70 hours

  • Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM

    After 22 hours, 46 hours and 70 hours

  • Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM

    After 22 hours, 46 hours and 70 hours

  • Area under the curve, COL-test

    After 22 hours and 70 hours

  • +5 more secondary outcomes

Other Outcomes (6)

  • International normalized ratio

    After 22 hours, 46 hours and 70 hours

  • APTT (activated partial thromboplastin time) in seconds

    After 22 hours, 46 hours and 70 hours

  • Fibrinogen in mol/l

    After 22 hours, 46 hours and 70 hours

  • +3 more other outcomes

Study Arms (2)

24 hours hypothermia

ACTIVE COMPARATOR

Therapeutic hypothermia for 24 hours after reaching target temperature

Other: Therapeutic hypothermia

48 hours hypothermia

EXPERIMENTAL

Therapeutic hypothermia for 48 hours after reaching target temperature

Other: Therapeutic hypothermia

Interventions

Therapeutic hypothermiaOTHER

Therapeutic hypothermia with a target temperature between 32-34°C.

24 hours hypothermia48 hours hypothermia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out of hospital cardiac arrest of presumed cardiac cause
  • Return of spontaneous circulation (ROSC)
  • Glasgow Coma Score \< 8
  • Age \> 18 years and \< 80 years

You may not qualify if:

  • \> 60 minutes from the circulatory collapse to ROSC
  • Time interval \> 4 hours from cardiac arrest to initiation of therapeutic hypothermia
  • Terminal illness
  • Coagulation disorder
  • Unwitnessed asystolia
  • Cerebral performance category 3-4 before the cardiac arrest
  • Severe persistent cardiogenic shock
  • Pregnancy
  • Persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment)
  • New apoplexy or intracerebral hemorrhage
  • Lack of consent from the relatives
  • Lack of consent from the GP
  • Lack of consent from the patient if he/she wakes up and is relevant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (2)

  • Jeppesen AN, Duez C, Kirkegaard H, Grejs AM, Hvas AM. Fibrinolysis in Cardiac Arrest Patients Treated with Hypothermia. Ther Hypothermia Temp Manag. 2023 Sep;13(3):112-119. doi: 10.1089/ther.2022.0037. Epub 2022 Dec 6.

    PMID: 36473198DERIVED

  • Jeppesen AN, Hvas AM, Duez CHV, Grejs AM, Ilkjaer S, Kirkegaard H. Prolonged targeted temperature management compromises thrombin generation: A randomised clinical trial. Resuscitation. 2017 Sep;118:126-132. doi: 10.1016/j.resuscitation.2017.06.004. Epub 2017 Jun 7.

    PMID: 28602694DERIVED

MeSH Terms

Conditions

HypothermiaHeart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Anni Norgaard Jeppesen, MD

    Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2014

First Posted

October 7, 2014

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2017

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

DK(1)